FRANCE — Ipsen, a French biopharmaceutical company, has concluded its acquisition of Albireo Pharma, a US-based rare disease specialist, in a deal valued at US$952 million.

The purchase, signed in January, saw Ipsen commence a tender offer to acquire Albireo’s outstanding shares through a fully-owned subsidiary.

As part of the agreement, the company paid US$42 per share for all issued and outstanding shares, along with US$10 a share for one non-transferable contingent value right (CVR).

Ipsen expects the deal to expand its rare disease portfolio, which includes therapeutics to treat pediatric and adult rare cholestatic-liver diseases.

The acquisition also adds two clinical-stage assets to Ipsen’s pipeline. The first, A3907, is an oral systemic apical sodium-dependent bile-acid transporter inhibitor being studied in a Phase II clinical trial for primary sclerosing cholangitis (PSC).

The second, A2342, is an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor currently being evaluated in a Phase I trial for viral and cholestatic diseases.

Albireo’s lead asset, Bylvay (odevixibat), is a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi) that received regulatory approval in the US in 2021 to treat pruritus in progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and above.

Bylvay also received approval to treat PFIC patients aged six months or above in the EU.

In addition, the US Food and Drug Administration (FDA) recently accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in pediatric and adult patients, with a Prescription Drug User Fee Act (PDUFA) action date of 15 June this year.

The acquisition of Albireo enhances Ipsen’s pipeline potential and scientific and commercial capabilities.

Ipsen CEO David Loew expressed excitement at welcoming new colleagues who have led the innovation on the development of novel bile acid modulators, like Bylvay, to treat rare liver diseases in children and adults.

With Ipsen’s global presence, the company will be able to bring the full potential of approved medicines to patients worldwide.

The acquisition of Albireo and its lead asset, Bylvay, is a strategic move by Ipsen to strengthen its portfolio in rare diseases.

Despite each rare disease affecting a relatively small number of individuals, there are over 7,000 distinct rare diseases that exist globally, and their collective impact on public health cannot be understated.

Currently, over 400 million people worldwide suffer from rare diseases, and this number is expected to continue growing.

However, despite the widespread prevalence of rare diseases, there are very few approved treatments available to those who are affected by them.

This lack of treatment options is due in part to the challenges associated with researching and developing therapies for rare diseases, which often lack the resources and attention afforded to more common diseases.

As a result, individuals with rare diseases face significant barriers to accessing effective care, and there is an urgent need to address these issues and improve outcomes for this population.

Given the scarcity of effective treatments for rare diseases, the acquisition of Albireo and its pipeline assets could prove to be a valuable addition to Ipsen’s offerings.

Several leading pharmaceutical companies have made strategic acquisitions in the rare disease therapy space in recent years, highlighting the growing importance of this field.

For example, BrightInsight and UCB have announced a collaboration to develop digital care solutions for rare diseases, with a focus on Myasthenia Gravis, a rare autoimmune disease affecting hundreds of thousands of people worldwide.

Similarly, Takeda has formed a partnership with Code Biotherapeutics to gain opt-in rights for four rare disease candidates, which will be developed using Code Bio’s targeted 3DNA non-viral genetic medicine delivery platform.

AstraZeneca has also made a significant investment in rare disease therapies by paying US$200 million for the rights to Ionis Pharmaceuticals’ investigational medicine, eplontersen.

This medicine is currently in Phase III clinical trials for amyloid transthyretin cardiomyopathy and polyneuropathy and is intended to treat both hereditary and non-hereditary forms of TTR amyloidosis.

Finally, Merck acquired Acceleron Pharma, a rare disease company in a deal worth US$11.5 billion aimed at expanding its pipeline of cardiovascular treatments and securing access to blockbuster drugs to boost future revenues.

These acquisitions underscore the increasing importance of rare disease therapies in the pharmaceutical industry and the need for continued investment in this area to address the unmet needs of patients with rare diseases.

They also highlight the importance of collaboration between pharma companies and digital health platforms to develop innovative solutions for rare disease management.

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